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companion diagnostic
Anthem Launches Program to Manage Genetic Tests
CEO SUMMARY: Pre-authorization of genetic tests is coming to physicians serving patients insured by Anthem, Inc. Its specialty benefits management company, AIM Specialty Health, will manage the program. AIM will work with InformedDNA, a company that specializes in genetic testing clinical…
July 25, 2016 Intelligence: Late Breaking Lab News
Throughout the profession of laboratory medicine, concern is surfacing following publication of a proposed rule by the Department of Veterans Affairs (VA) that would expand the authority of Advanced Practice Registered Nurses (APRNs) to supervise and perform laboratory testing. This …
Detroit Hospital Develops 10 Ways To Add More Value
CEO SUMMARY: Clinical labs are beginning to make the transition from a volume-based financial model to a model based on value-based payments. To survive this transition, labs must find ways to create value. The lab at Henry Ford Health System has identified 10 ways that it c…
Investment Bank Bullish On Clinical Labs, Pathology
CEO SUMMARY: For clinical laboratories and anatomic pathology groups willing to adapt to the evolving needs of the American healthcare system, there are many positive opportunities. That’s the view of a Wall Street investment bank that just published a report on the lab testing…
Opko Pays $1.47 Billion to Buy Bio-Reference Lab
CEO SUMMARY: It’s a case of the little fish gobbling the big fish, as Opko Health – with revenue of $91 million – will be acquiring Bio-Reference Laboratories, with revenue of $832 million. But the more interesting aspect of the story is that the CEO of Opko Health is a physi…
February 17 Intelligence: Late Breaking Lab News
GeneCentric is a new lab testing company in Durham, North Carolina that was started by former executives of Laboratory Corporation of America. It intends to raise $20 million in a Series B capital offering. GeneCentric’s business model is to license molecular diagnostic tests, then develop the…
Labs Share Successes in Delivering More Value
CEO SUMMARY: As the number of accountable care organizations and patient-centered medical homes grows monthly, a handful of innovative labs are seizing the opportunity to develop and deliver lab testing services that add more value to physicians and patients. These early-adopter labs reco…
FDA Notifies Congress that It Will Regulate LDTs
CEO SUMMARY: Since 2006, the FDA has said it has the authority to regulate lab-developed tests, but it has held off on doing so. Now the agency says it’s time, defining LDTs as being, “designed, manufactured, and used within a single laboratory. LDTs include some genetic tests and tes…
November 11, 2013 “Intelligence: Late Breaking Lab News”
Who would have guessed that Angelina Jolie would do a multi-million-dollar favor to Myriad Genetics, Inc.? Jolie caused quite a stir earlier this year when she went public with the news that she had done a prophylactic double mastectomy after she had learned the results of her BRCA test for br…
Newsmaker Interview: Adam Slone, Tara Kochis
“When it comes to hiring senior leaders, labs today are more diligent in recruiting and interviewing candidates for key executive and management positions. One reason for this change is the shrinking financial margins at most labs.” …
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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